17 results · 22ms · Sources: EU EUDAMED, US FDA

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MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF)

FDA 510(k)
FDA Class 2 ·Anesthesiology

SchureMed

FDA UDI
SCHUERCH CORPORATION·00810014605852·AMSCO 1080/2080 3PC PAD SET 2 1/4 DELUXE W/GEL

ENDOCARE PERCUTANEOUS ACCESS SET

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

DORNIER DIODE LASER FAMILY MEDILAS D, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT-FULLY COVERED

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code ESW·March 25, 2015

TENSION FREE VAGINAL TAPE

FDA Adverse Event
Injury ·ETHICON INC·Product code PAH·April 26, 2013

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 6, 2011

MAMMOTOME EX HOLSTER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code KNW·July 24, 2008

EVOLUTION BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FAD·March 12, 2015

EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code ESW·November 12, 2014

EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code ESW·November 27, 2014

EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code ESW·November 24, 2014

BUTTRESS/COMPRESSION NUT FOR 357.369

FDA Adverse Event
Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HST·July 18, 2018

ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FCG·August 29, 2019

Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

FDA Enforcement
Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018